Abstract
Purpose
To estimate the efficacy and safety of 5 mg and 10 mg mifepristone for emergency contraception up to 144 hours after unprotected coitus.
Methods
This double-blind randomized clinical trial was carried out at Eusebio Hernandez Hospital (Havana, Cuba). A total of 2,418 women who requested emergency contraception after unprotected coitus received either 5 mg or 10 mg mifepristone. The variables for assessing efficacy were the pregnancies that occurred and the fraction of pregnancies that were prevented. Other variables assessed were the side effects of mifepristone, vaginal bleeding, and changes in the date of the following menstruation.
Results
There were 15/1,206 (1.2%) and 9/1,212 (0.7%) pregnancies in the 5 mg and 10 mg group, respectively (P=0.107). There were 88% and 93% prevented pregnancies in the 5 mg and un ≥7 days was experienced by 4.9% and 11.0% of subjects in the 5 mg and 10 mg group, respectively (P=0.001). There was a significant high failure rate for women weighing >75 kg in the 5 mg group.
Conclusion
It would be advisable to use the 10 mg dose of mifepristone for emergency contraception as there was a trend suggesting that the failure rate of the larger dose was lower.
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Acknowledgments
The authors are much indebted to Iris Villa Gener and Robert McKnight for their invaluable collaboration in the completion of this study.
Disclosure
The authors report no conflicts of interest in this work.